Project Summary

The growth in therapeutic choices for many conditions has sparked interest in evaluating the comparative effectiveness of these alternatives. Randomized clinical trials frequently do not provide direct comparisons of treatments and have limitations for certain conditions and/or population subgroups. Although the information value of non-randomized research is appreciated by many, critics often point to methodological weaknesses inherent in observational studies, coupled with the lack of standard principles to assess their quality, as practical limitations to their effective use in evidence development.

A well-defined and consensus-driven set of principles could serve to guide good practice for observational studies of comparative effectiveness, both for those who conduct these studies and for those who need to understand how such studies can be used appropriately to support decision-making regarding therapeutic alternatives. The GRACE initiative is developing a core set of good practice principles to address the design, conduct, analysis, and reporting of observational studies of comparative effectiveness.

Presentations and Listening Sessions

The GRACE Principles have developed as a result of the individual contributions of our collaborators, review from the International Society of Pharmacoepidemiology membership, and from contributions at the following events:

• HTAi presentation, 7th Annual Conference, June 7, 2010, Dublin, Ireland

• International Society of Pharmacoepidemiology Call for Comments from the ISPE Membership. 8 January 2010.

• GRACE Principles workshop at 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management: 'Developing Good Practice Guidance for Non-Randomized Studies of Comparative Effectiveness: A Workshop on Quality and Transparency'. 18 August 2009, Providence, Rhode Island.

• GRACE Principles presentation at DIA's 6th Canadian Annual Meeting. 5-7 November 2008, Ottawa, Ontario.

• Open meeting to discuss proposed principles. 30 June 2008, Boston, Massachusetts.

• ISPOR Issue Panel: "Are Good Practice Principles for Observational Comparative Effectiveness Research Needed?" Panelists: Nancy A. Dreyer, Marc L. Berger, Sean D. Sullivan, Jaques Lelorier. 6 May 2008, Toronto, Ontario.

• Presentation to DEcIDE Centers and CERTS on the Principles at the Agency for Healthcare Research and Quality (AHRQ). 30 April 2008, Rockville, Maryland.

• Open meeting to discuss proposed principles. 16 April 2008, Boston, Massachusetts.